Examination of the Maternal Serum Pepsinogen-1 in Patients Diagnosed With Severe Hyperemesis Gravidarum: A Prospective Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pepsinogen-1 serum level
研究概览
简要总结
In this study, the investigators planned to investigate maternal serum pepsinogen-1 (MSPG-1) levels in pregnant women with severe hyperemesis gravidarum (HG) and pregnant women without severe HG.
HG is the most common cause of hospitalization in the first trimester of pregnancy and represents an economic burden on the healthcare system. Therefore, our aim in this study was to investigate whether there is a statistical difference in MSPG-1 levels between pregnant women with severe HG and pregnant women without severe HG and to determine a cut-off value for MSPG-1 levels for the indication of hospitalization of pregnant women with HG.
The study poses no risk to the pregnant woman or the fetus.
详细描述
The study will enroll pregnant women in the first trimester with maternal age between 21 and 35 years who were diagnosed with hyperemesis gravidarum and had no fetal congenital or chromosomal abnormalities and who were admitted to the perinatology outpatient clinic of Etlik City Hospital. The investigators will include 40 cases with no signs and diagnosis of systemic maternal disease and no chronic drug use as a case group and 40 healthy pregnant women matched for age, gestational week and body mass index as a control group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A singleton pregnancy
- •Between 21 and 35 years old
- •Diagnosis of hyperemesis gravidarum
排除标准
- •Multiple pregnancy
- •Fetal congenital and chromosomal abnormalities
- •Chronic drug use, alcohol and smoking
- •Pregnant women with diabetes or obesity, peptic ulcer or gastritis, liver and/or gallbladder disease (cholangitis or gallstones), thyroid dysfunction, urinary tract infection, celiac disease, cardiovascular or renal disease
结局指标
主要结局
Pepsinogen-1 serum level
时间窗: between 5 and 14 weeks of pregnancy
pepsinogen-1 serum level was determined with blood samples taken from pregnant women with hyperemesis gravidarum and control group.
次要结局
未报告次要终点
研究者
Fahri Burcin Firatligil
Specialist doctor in obstetrics and gynecology and Fellow student in Perinatology
Ankara Etlik City Hospital